Trial Outcomes & Findings for Efficacy and Acceptability of Two Lubricant Eye Drops (NCT NCT00756678)

Results Overview

Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

1 week

Results posted on

2011-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients All patients
Overall Study STARTED	51
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Acceptability of Two Lubricant Eye Drops

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=51 Participants All patients
Age, Customized <=40 years	22 participants n=5 Participants
Age, Customized Between 40 and 65 years	24 participants n=5 Participants
Age, Customized >=65 years	5 participants n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure

Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.

Outcome measures

Outcome measures
Measure	Lubricant Eye Drops (Optive™) n=50 Participants Lubricant Eye Drops (Optive™)	Lubricant Eye Drops (Blink® Tears) n=50 Participants Lubricant Eye Drops(blink® Tears)
Mean Frequency of Eye Drop Use Over 1 Week	1.76 Use per day Standard Deviation 0.89921	1.66 Use per day Standard Deviation 0.94459

SECONDARY outcome

Timeframe: Baseline, Day 16

Population: Intent to Treat; defined as all randomized (started study) patients. Of the 51 randomized patients, data from 49 patients were evaluated for this outcome measure.

Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.

Outcome measures

Outcome measures
Measure	Lubricant Eye Drops (Optive™) n=49 Participants Lubricant Eye Drops (Optive™)	Lubricant Eye Drops (Blink® Tears) n=49 Participants Lubricant Eye Drops(blink® Tears)
Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 Baseline	4.65 Scores on a scale Standard Deviation 1.843	4.62 Scores on a scale Standard Deviation 1.839
Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16 Day 16	-1.41 Scores on a scale Standard Deviation 2.010	-1.47 Scores on a scale Standard Deviation 1.905

SECONDARY outcome

Timeframe: Day 16

Population: Intent to treat; defined as all randomized (started study)patients. Of the 51 randomized patients, data for 50 patients were evaluated for this outcome measure

Percentage of patients who responded "Strongly Agree" and "Agree" to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are "Strongly Agree", "Agree", "Neither Agree or Disagree", "Disagree" and "Strongly Disagree".

Outcome measures

Outcome measures
Measure	Lubricant Eye Drops (Optive™) n=50 Participants Lubricant Eye Drops (Optive™)	Lubricant Eye Drops (Blink® Tears) n=50 Participants Lubricant Eye Drops(blink® Tears)
Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16	86 Percentage of Patients	78 Percentage of Patients

SECONDARY outcome

Timeframe: Day 16

Population: Intent to Treat; defined as all randomized (started study) patients.

Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.

Outcome measures

Outcome measures
Measure	Lubricant Eye Drops (Optive™) n=51 Participants Lubricant Eye Drops (Optive™)	Lubricant Eye Drops (Blink® Tears) n=51 Participants Lubricant Eye Drops(blink® Tears)
Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16	16 Number of patients	22 Number of patients

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER